Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thymectomy (SPRATS)

March 20, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Use of Serratus Posterior Superior Intercostal Plane Block in Robotic-Assisted Thoracoscopic Surgery for Thymectomy: A Randomized Controlled Trial

This study aims to assess the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) for postoperative pain control, reducing opioid analgesic consumption, minimizing postoperative respiratory complications, and enhancing patient satisfaction (measured using the QoR-15 index) in patients undergoing robotic thymectomy, compared to patients who do not receive the block.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients enrolled in the study will receive the SPSIP Block under ultrasound guidance 15 minutes before entering the operating room. The SPSIP Block will be performed by the attending anesthetist (investigator 1), who will use a syringe pre-filled with 30 ml of a solution prepared in advance by another investigator (investigator 2). According to the randomization scheme, the solution in the syringe used for the SPSIP Block will contain either 0.25% bupivacaine for 50% of the cases (SPSIP group) or sterile saline solution (0.9% NaCl) for the remaining 50% of the cases (control group). Postoperatively, data collection will be managed by a third investigator (investigator 3). Neither the investigator 1, the patient, nor the investigator 3 will be informed of the syringe's contents, ensuring the study is conducted blind.

All patients enrolled in the study will receive 1000 mg of paracetamol and 30 mg of ketorolac at the end of the surgery, during skin closure. Additionally, upon arrival in the recovery room, all patients will be connected to a PCA (Patient Controlled Analgesia) pump filled with a solution containing opioids. Patients who have NPRS scores greater than 4 during postoperative pain reassessments, despite PCA use, will be given a rescue analgesic dose of 1000 mg of paracetamol (which can be repeated after 8 hours, up to a maximum of 3000 mg in 24 hours).

Postoperative pain intensity will be assessed by investigator 3 at 0, 2, 6, 12, and 24 hours after the end of surgery using the Numeric Pain Rating Scale (NPRS). Assessments will be conducted both at rest and during coughing. Total opioid and rescue analgesic consumption, incidence of postoperative complications, and length of hospital stay will also be recorded. Twenty-four hours after the surgery, investigator 3 will administer the Quality of Recovery 15 (QoR-15) questionnaire to all patients enrolled in the study. The responses will be used by investigator 3 to calculate the QoR-15 Index, which summarizes the degree of patient satisfaction.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients affected by thymoma, thymic hyperplasia, or thymic pathologies (cysts, teratomas) who have given informed consent to the study.

Exclusion Criteria:

  • Patients who refuse to participate in the study by not signing the informed consent;
  • Patients with myasthenia gravis, severe obesity (BMI > 35), history of OSAS with or without CPAP;
  • Patients belonging to ASA classes > 3, according to the system developed by the American Society of Anesthesiologists;
  • Patients unable to understand the functioning of the NPR Scale or the PCA device that will be used for postoperative analgesia;
  • Patients with allergies to analgesic and/or anesthetic drugs;
  • Patients on anticoagulant therapy;
  • Patients with a history of chronic pain;
  • Patients with an infection at the site where SPSIPB will be performed;
  • Patients who have had previous thoracic surgery and/or thoracic trauma with rib fractures on the side of the surgery;
  • Patients with chest deformities and/or neuromuscular diseases that interfere with normal ventilatory function.

Additionally, patients whose surgery is intraoperatively converted to sternotomy thymectomy will be excluded post-hoc from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPSIP group
Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed by administering 30 ml of 0.25% bupivacaine.
Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with 0.25% bupivacaine
While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.25% bupivacaine is administered superficially to the intercostal muscle.
Other Names:
  • SPSIP Block with 0.25% bupivacaine
Placebo Comparator: Placebo group
Patients in this group will be treated with the Serratus Posterior Superior Intercostal Plane Block, administered under ultrasound guidance 15 minutes before surgery in the operating room. The block will be performed using 30 ml of a placebo solution without an active ingredient (0.9% NaCl)
Procedure: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block performed with a placebo solution (0.9% NaCl)
While the patient is in the prone or the sitting position, a high-frequency linear transducer is placed transversely at the level of the scapular spine, visualizing the upper medial border of the scapula, trapezius muscle, rhomboid major, serratus posterior superior muscle, and the second and third ribs. Next, the transducer is rotated to obtain an oblique view, including the upper medial border of the scapula. The needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs to reach the fascial plane between the serratus posterior superior muscle and intercostal muscles using the in-plane technique. Once the needle contacts the rib, 30 mL of 0.9% NaCl is administered superficially to the intercostal muscle
Other Names:
  • SPSIP Block with placebo solution (0.9% NaCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: 0, 2, 6, 12, and 24 hours after the end of the surgical procedure
The measurement of postoperative pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a numerical scale that can range from 0 to 10 (where 0 means no pain and 10 corresponds to the worst imaginable pain), in the two study groups.
0, 2, 6, 12, and 24 hours after the end of the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid drug consumption
Time Frame: 24 hours after surgery
The total number of opioid doses administered via a Patient Controlled Analgesia (PCA) device in the first 24 hours after surgery
24 hours after surgery
Consumption of rescue analgesics
Time Frame: 24 hours after surgery
The total dose of acetaminophen administered upon the patient's request during the first 24 postoperative hours
24 hours after surgery
postoperative respiratory complications
Time Frame: 24 hours after surgery
The number of any postoperative respiratory complications in the two study groups
24 hours after surgery
postoperative quality of recovery
Time Frame: 24 hours after surgery
the patient's level of satisfaction measured using the QoR-15 index, a numerical parameter calculated by administering the Quality of Recovery 15 (QoR-15) questionnaire to the patient
24 hours after surgery
Length of Hospital Stay
Time Frame: from the end of the surgical procedure to patient discharge
the duration of postoperative hospitalization
from the end of the surgical procedure to patient discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Dania Nachira, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Principal Investigator: Giovanni Punzo, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6729

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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